INSTITUTE DR. RILLING INC. · 89-08 · GERMANY
For INSTITUTE DR. RILLING INC., import alert is 89-08; country is GERMANY; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is BioScan SWA Skalar-Wave Analyzer | BioScan SWA Skalar-Wave Analyzer; product code is 74 M - - SX System, Network and Communication, Physiological Monitors | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief; date published is 05/30/2017; address is Lilienthalweg 13 , Pliezhausen, GERMANY, verified against its source on 2026-09-30.
- Firm
- INSTITUTE DR. RILLING INC. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- GERMANY verified
- Address
- Lilienthalweg 13 , Pliezhausen, GERMANY verified
- Date published
- 05/30/2017 verified
- Product code
- 74 M - - SX System, Network and Communication, Physiological Monitors | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief each item verified
- Product
- BioScan SWA Skalar-Wave Analyzer | BioScan SWA Skalar-Wave Analyzer each item verified
- FDA notes
- Class II device without a valid 510k | Class II device without a valid 510k each item verified
What the source says
INSTITUTE DR. RILLING INC. Date Published : 05/30/2017 Lilienthalweg 13 , Pliezhausen, GERMANY
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
74 M - - SX System, Network and Communication, Physiological Monitors Date Published: 05/30/2017 Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 05/30/2017 Desc: BioScan SWA Skalar-Wave Analyzer Notes: Class II device without a valid 510k
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html